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The Relationship Between Renal Functions and Multi Drug Resistant Organisms

Sponsor
Konya Numune Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04833231
Collaborator
(none)
133
Enrollment
1
Location
18
Actual Duration (Months)
7.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Ventilator-associated pneumonia (VAP) is the most common nosocomial infection in patients receiving invasive mechanical ventilation (MV). Antibiotic resistance poses an increasing threat due to the rise of infections caused by multidrug-resistant organisms (MDROs).Despite the increase in the frequency of MDRO colonisation and infection in dialysis patients, it is not known enough whether the risk of multi-drug resistant (MDR) pneumonia increases in mild-to-severe chronic kidney disease (CKD) (eGFR <60 mL/min/1.73 m2) patients not receiving dialysis. Therefore, in our study, the investigators aimed to evaluate the relationship between renal functions and MDR VAP risk and the specific microbial pattern.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This prospective observational study was performed on adult patients intubated and receiving MV for at least 48 hours in the 42-bed surgical and medical Intensive Care Unit. The study was conducted between August 2019 and January 2021 and approved by the Ethics Committee of Necmettin Erbakan University Medical School. Informed consents were obtained from patients participating in the study or from their relatives. The characteristics of patients with MDRO infection associated with different eGFR categories in VAP patients were recorded.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    133 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Relationship Between Renal Functions and Multi Drug Resistant Organisms in Patients With Ventilator Associated Pneumonia
    Actual Study Start Date :
    Aug 1, 2019
    Actual Primary Completion Date :
    Jan 15, 2021
    Actual Study Completion Date :
    Jan 31, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    High eGFR group (eGFR ≥60 mL/ min/1.73 m2)

    Patients with estimated glomerular filtration rate (eGFR) ≥60 mL/ min/1.73 m2 as high eGFR group
    Low eGFR group (eGFR <60 mL/min/1.73 m2)

    Patients with estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 as low eGFR group

    Outcome Measures

    Primary Outcome Measures

    1. Multi-drug resistant (MDR) pneumonia [18 months]

      The presence of an infection with a resistant pathogen in patients with impaired renal function (eGFR <60 mL/min/1.73 m2) served as our primary outcome measure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients of 18 years of age and above

    • A clinical suspicion of VAP as defined in the American Thoracic Society (ATS) guidelines

    • A Clinical Pulmonary Infection Score (CPIS) > 6

    • No signs and symptoms of infection at the time of admission to the ICU

    Exclusion Criteria:

    • Acute kidney injury

    • Renal replacement treatment (RRT)

    • Dialysis

    • Renal transplantation

    • Active tuberculosis

    • Malnutrition

    • Immunosuppression (neutropenia, HIV positivity, transplantation, prednisone treatment of ≥20 mg/day, etc.)

    • Any extrapulmonary infection other than VAP at the time of being included in the study

    • Respiratory cultures presented fungal agents

    • Normal flora

    • No growth

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Konya Numune Hospital Konya Turkey 42060

    Sponsors and Collaborators

    • Konya Numune Hospital

    Investigators

    • Principal Investigator: Omur ILBAN, MD, Konya Numune Hospital, Department of Intensive Care

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Omur ILBAN, Principal investigator, Konya Numune Hospital
    ClinicalTrials.gov Identifier:
    NCT04833231
    Other Study ID Numbers:
    • omurilban1
    First Posted:
    Apr 6, 2021
    Last Update Posted:
    Apr 6, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Kidney Diseases
    Renal Insufficiency, Chronic

    Study Results

    No Results Posted as of Apr 6, 2021